The Hepatitis B Research Network Pediatric Hepatitis B Natural History Study for patients and family members

The main goal of the study is to learn more about hepatitis B virus (HBV) infection in children.

The HBRN Pediatric Hepatitis B Natural History StudyThe main goal of the study is to learn more about hepatitis B virus (HBV) infection in children. For several years, researchers will follow, evaluate, and describe a large group of children. They will confidentially collect a child’s medical history, laboratory values, family history, and demographic information. The investigators will carefully examine the study data to understand how the HBV infection progresses and how it impacts the lives of these children and their families. The information learned may help guide treatment and prevention studies and identify the best way to treat HBV infection in children.

A second goal of the study is to create a large bank of blood and tissue samples obtained from children enrolled in the study. These valuable samples may help scientists learn more about the Hepatitis B Virus, develop new medical tests, treatments, and ways to prevent disease progression.

Frequently Asked Questions

Who can enroll?Generally children ages 6 months to less than 18 years who are Hepatitis B Surface Antigen positive. The reasons a child may not be eligible for the study are listed below.

Who is not eligible?

Children with any of the following are not able to enroll in this study:

Taking medication(s) for Hepatitis B

Taking medication(s) which suppress the immune system such as corticosteroids taken by mouth

Hepatic decompensation (significant damage has occurred in the liver and it is no longer working properly)

Undergone organ or bone marrow transplant

Liver Cancer

HIV infection

What if my child needs medication for Hepatitis B while in the study?After enrollment in the study, any child that needs treatment may receive standard HBV medication as prescribed by their doctor. These children will remain in the study as their response to treatment provides valuable information. Children in the study who need to start HBV medication(s) may qualify for a HBRN treatment trial.

Where is the study taking place?The HBRN Pediatric Cohort study is being conducted by researchers at locations in the United States and Canada (www.hepbnet.org).

Who do I contact for more information about the study?You can contact the enrollment ((www.hepbnet.org) at your nearest pediatric HBRN site for further details.

How many children will be enrolled in the study?Approximately 500 children will be enrolled in this study over the 24 months.

Is there a cost to being in the study?No. It will not cost you anything to participate. The National Institute of Health (NIH) is paying for this study to be conducted. However the routine clinical visits and laboratory analyses will be billed to you or to your insurance as usual.

Will my child benefit from being in the study?A child will not benefit directly from enrolling in the study. However, the knowledge gained from their participation may help other children who have this disease.

Will anyone know my child in participating in the study?Participation in this study will be kept confidential. At the enrollment visit each participant is assigned a unique study identification code. This code is used to label all information and samples collected for research purposes.

How long does the study last?This study lasts for up to 6 years. However, the age of the child at the time of their enrollment will determine the actual length of participation.

How many visits are included in the study?In the first year there are three visits (enrollment, 6 month and 12 month follow up). In the remaining years there is one annual visit.

What will be done at the enrollment visit?At the first visit a physical examination and a detailed medical history of your child will be taken. Much of this information can be found by reviewing a child’s medical records and laboratory reports. You and your child (depending on their age), will complete brief Quality of Life surveys. If you give permission, we will also collect from your child, samples of blood for research. These samples are labeled and stored by the child’s unique study code. The collection of additional blood for research is optional.

What will happen at follow-up visits?Visits will include a physical exam, interval history and laboratory tests. Some visits will include completion of the same Quality of Life surveys. With your permission, we would again collect your child’s blood for research. It may be possible to coordinate some or all of the research visits at the same time as your child’s clinical visits.

What if my child needs to drop out of the study?Your child’s participation is voluntary and your child is free to leave the study at any time.